This invention pertains to medical grade film and a method of sterilizing medical grade film and, more particularly, to medical grade film and a method of sterilizing the same wherein the film can be gamma or electron beam sterilized without any color change, and the sterilized medical grade film produced thereby.
Medical grade film, e.g., film meeting the requirements of Class VI plastics as set forth in the U.S. Pharmacopeia, Volume XX, is useful for manufacturing products which can be used for medical treatments and for manufacturing containers for products such as pharmaceuticals, cosmetics and foods. Suitable applications for such films are enteric feeding bags, kidney dialysis bags, barium enema bags, colostomy bags, bloodwashing bags, blood storage bags, urinary drainage bags, incontinent products, inflatable splints, hospital I.D. bracelets, traction devices, burn mattresses, comfort cushions and waterproof hospital sheeting.
Currently, the medical industry utilizes a medical grade film containing polyvinyl chloride (PVC) resin. The industry sterilizes this medical grade film using ethylene oxide. However, this is a cumbersome, time-consuming and expensive method of sterilization. The industry prefers using the gamma-radiation sterilization method since it is more effective biologically, less expensive and less time-consuming. However, irradiation levels of 1 to 5 megarads used in this sterilization method cause the polyvinyl film to yellow. While this yellowing does not render the film nonfunctional, it is considered undesirable aesthetically.